UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Title of the study (Brief title)	A Comparative study of efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops.
Region	Japan

Condition
Condition	primary open angle glaucoma or ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate and compare efficacy and safety of Tapcom combination ophthalmic solution and Xalacom combination eye drops in patients with primary open angle glaucoma or ocular hypertension in a multi-center exploratory clinical study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IOP Change from baseline at the end of treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tapcom combination ophthalmic solution, QD for 12weeks
Interventions/Control_2	Xalacom combination eye drops, QD for 12weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who can visit the hospital according to the observation/test schedule determined in the study protocol Those with disease of which the principal investigator or subinvestigator considers requiring treatment by using a fixed dose combination drug containing a prostaglandin and a beta blocker.
Key exclusion criteria	There is risk of visual field disorder drastically progressing during the study period. Has retinal which may aggravate during the study period. Has active extraocular disease, inflammation or infection of the eye or eyelids Has corneal abnormalities or other diseases which would prohibit accurate IOP measurement by Goldmann applanation tonometer Has undergone LASIK surgery Patients who are contraindicated to beta blockers (those who with bronchial asthma or insufficiently controlled heart failure) Patients with allergy to the ingredients used in the present study Female who is pregnant, lactating, or may possibly be pregnant , wishes to become pregnant during the study period, or cannot use appropriate contraceptive method.
Target sample size	150

Research contact person
Name of lead principal investigator	Masayo Hashimoto
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs, Development Management Department, Japan Business
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9337
Email	clinical@santen.co.jp

Public contact
Name of contact person	Naomi Otsuka
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs, Development Management Department, Japan Business
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9603
Homepage URL
Email	clinical@santen.co.jp

Sponsor
Institute	Santen Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 21 Day
Anticipated trial start date	2016 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Medical Adviser, Yasuaki Kuwayama, Fukushima eye clinic(Osaka)

Management information
Registered date	2016 Year 08 Month 31 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027484